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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K221759
Device Name Cornisol
Applicant
Aurolab
#1, Sivagangai Main Rd.
Veerapanjan, Madurai,  IN 625020
Applicant Contact Krishna Kumar
Correspondent
Allied Regulatory Consulting
1540 Keller Pkwy., Suite 108 #170
Keller,  TX  76248
Correspondent Contact Sean Griffin
Classification Product Code
LYX  
Date Received06/17/2022
Decision Date 10/05/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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